Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22082
Brand Name:Balt COPERNIC2L Occlusion Balloon Catheter
Model:
Affected:all lots
Software version:
Recalling Organisation:Getz Healthcare Limited
Level 17
120 Albert Street
Auckland
Contact Information:0800 733 333
Manufacturer:Balt Extrusion SAS
Brand Name:Balt ECLIPSE2L Occlusion Balloon Catheter
Model:
Affected:All lots
Software version:
Recalling Organisation:Getz Healthcare Limited
Level 17
120 Albert Street
Auckland
Contact Information:0800 733 333
Manufacturer:Balt Extrusion SAS
Issue:Post market surveillance has identified damages on the catheter tubes which may lead to unexpected inflation and difficult deflation to the balloon duing the contrast liquid injection through the guiding catheter.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:20/10/2017
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